ClinicalTrials.gg
RecruitingNCT07776613Updated Aug 20, 2026

A Study of Romosozumab in People With Breast Cancer and Osteoporosis

A Phase 2 interventional study of Romosozumab in Breast Cancer and Metastatic Breast Cancer (MBC), sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 253 studies in Breast Neoplasms by Memorial Sloan Kettering Cancer Center — 47 open to participants now, 98 under way, 3 of them phase 3. Breast Neoplasms · Memorial Sloan Kettering Cancer Center.

Planned enrollment
114th of 156
25 · median 51
Started
2026
with 10 others
Phase 2
52 of 253
14 open now
Primary completion
2028-08
later than 77 of 97 live
Registered
250th of 253
by date

Among the 253 studies in Breast Neoplasms by Memorial Sloan Kettering Cancer Center, this one is the 114th largest by planned enrollment of the 156 interventional ones that give a count, is one of 11 that started in 2026, is one of 52 in phase 2, reaches primary completion later than 77 of the 97 other live ones, and was the 250th registered.

Breast Neoplasms

14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

47 of the 253 studies in Breast Neoplasms by Memorial Sloan Kettering Cancer Center are open now, in 4 countries. Recruiting first, the newest first:

41 more — sign in →

By country, each count listing its studies:

All 47 open studies →

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 253 studies in Breast Neoplasms by Memorial Sloan Kettering Cancer Center, or all of them as a file.
02

Study summary

The researchers are doing this study to see if romosozumab is effective at helping with bone formation in people with metastatic breast cancer (MBC) that has spread to the bones. All participants will have osteoporosis. The researchers will also look at bone breakdown (resorption) in participants and determine if romosozumab is a safe treatment for osteoporosis in people with MBC that has spread to the bones.

03

Conditions studied

  • Breast Cancer
  • Metastatic Breast Cancer (MBC)

Browse trials for

Keywords

  • Romosozumab
  • 26-191
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 years of age at the time of giving ;
  • Patients diagnosed with hormone-receptor positive (ER/PR >1%) breast cancer to bones on any endocrine therapy with or without targeted therapy (i.e. CDK 4/6 inhibitors, PI3K inhibitors, anti--therapy);
  • Evidence of osteoporosis on dual X-ray absorptiometry (DXA) scan; must following:
  • osteoporosis on dual X-ray absorptiometry (DXA) scan; or history of fragility fracture of the spine or hip; or of morphometric spine fracture;

Exclusion criteria

Exclusion Criteria:

  • Prior therapy with a bone-modifying agent (intraveous bisphosphonates or subcutaneous denosumab) for bone disease;
  • 25 (OH) vitamin D levels \< 20 ng/mL; Vitamin D repletion will be permitted and subjects will be be rescreened once 25 (OH) vitamin D level ³ 20 ng/mL;
  • History of myocardial infarction or stroke within the preceding year;
  • Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range per institutional standard (\<8.5 or >10.5 mg/dL); Calcium repletion will be permitted and subjects will be be rescreened once values are within the institutional standard.
  • History of non-healed dental or oral surgery;
  • History of osteonecrosis of the jaw
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Romosozumab

    Romosozumab will be given on-label at 210 mg

    Drug: Romosozumab

Interventions

  • Romosozumab will be given on-label at 210 mg administered SC once monthly for 12 months.

06

What researchers measure

Primary outcomes

  1. Percent change in Procollagen Type 1 N-telopeptide (P1NP ) levels

    Blood samples for the panel of bone turnover markers

    Time frame: 1 year

07

Study locations

7 of 7 sites recruiting
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Monica Fornier, MD · Contact6468884563
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Monica Fornier, MD · Contact646-888-5240
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Monica Fornier, MD · Contact646-888-5240
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
    Commack, New York 11725, United States
    Recruiting
    • Monica Fornier, MD · Contact646-888-4563
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    Harrison, New York 10604, United States
    Recruiting
    • Monica Fornier, MD · Contact646-888-4563
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
    • Monica Fornier, MD · Contact646-888-5240
    • Jasmeet Singh, MD · Contact914-367-7358
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
    Uniondale, New York 11553, United States
    Recruiting
    • Monica Fornier, MD · Contact646-888-4563
08

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2028, 24 months after the start.

Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 89. This study's planned 24 months is below that.

Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
Aug 17, 2026
Primary completionEst.
Aug 2028
CompletionEst.
Aug 2028
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07776613
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Aug 17, 2026
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Aug 20, 2026

Study contacts

Monica Fornier, MD
Contact
fornierm@mskcc.org
646-888-5240
Jasmeet Singh, MD
Contact
914-367-7358

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Romosozumab

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